MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE 3ML LL W/NDL 22X1 RB; PISTON SYRINGE

Catalog Number 309572

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that syringe 3ml ll w/ndl 22x1 rb needle broke.The following information was provided by the initial reporter: material no: 309572, batch no: unknown (provided 0208010) it was reported needle broke on the site.Verbatim: consumer reported - removed the needle from site after injection with testosterone, and the needle was missing.Not found on the floor.Consumer reported - went to first doctors visit (b)(6) 2021 for a consult for this incident.Doctor looked at this site that he circled with ink.They will complete an xray on (b)(6) 2021 of the site marked plus a cysts that he has had before this incident.Date of event: (b)(6) 2021 samples status - discarded one in question.Sending mailing kit for unused samples.From phone call on 2021-01-19 09:50:21: called and left a voice message on this consumers voice mail.Consumer did not reply to the email that i sent to obtain the item and lot number as requested.Dc per update in snow by us com added on 01/18/2021 from phone call on 2021-01-15 14:55:12: called this consumer.He is currently not at home again.Updated this case with consumer address.Consumer informed he was taking his testosterone injection on (b)(6) 2021 and when removed the needle from site the needle was missing.Does not feel it was a retracting syringe but not sure of item # or lot # still.Denied reuse of syringes.Consumer went to first doctors visit (b)(6) 2020 for a consult for this incident.Doctor looked at this site that he circled with ink.They will complete an xray on (b)(6) 2021 of the site marked plus a cysts that he has had before this incident.Consumer provided his email address.I will email him so he can update the contact tonight when he gets home.Sending mailing kit to home address for unused syringes from his supply.Wife discarded syringe in question.Dc from phone call on 2021-01-14 16:30:33: called out to this patient/consumer got him while he was driving to doctors for a review visit.Not able to ask a lot of questions or obtain product info.He does not know the item number at this time but will update bd tomorrow afternoon (b)(6) 2021.Dc email from rcc - consumer left voice message saying that he uses bd injection needles for testosterone injections.He reported that 1 or 2 have dislodged from the head of the needle and is currently stuck in his left backside.The consumer would like to know if he needs to get it out immediately and if there will be any damage consumer reported lot #: catalog#: date of event: samples status i tried to reach out to customer to get additional information.Left a voice message and advise someone would follow up.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/9/2021.H.6.Investigation: one 3ml syringe with needle attached in a fully sealed blister pack from batch 0206010 (p/n 309572) was received and evaluated.The cannula and hub were visually inspected and appeared to be securely attached.No defects were observed.The reported defect was not identified in the samples received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

It was reported that syringe 3ml ll w/ndl 22x1 rb needle broke.The following information was provided by the initial reporter: material no: 309572 batch no: unknown (provided 0208010) it was reported needle broke on the site.Verbatim: consumer reported - removed the needle from site after injection with testosterone, and the needle was missing.Not found on the floor.Consumer reported - went to first doctors visit (b)(6) 2021 for a consult for this incident.Doctor looked at this site that he circled with ink.They will complete an xray on (b)(6) /2021 of the site marked plus a cysts that he has had before this incident.Date of event: (b)(6) 2021.Samples status - discarded one in question.Sending mailing kit for unused samples.From phone call on (b)(6) 2021 09:50:21: called and left a voice message on this consumers voice mail.Consumer did not reply to the email that i sent to obtain the item and lot number as requested.Dc per update in snow by us com added on on (b)(6) 2021.From phone call on 2021-01-15 14:55:12: called this consumer.He is currently not at home again.Updated this case with consumer address.Consumer informed he was taking his testosterone injection on (b)(6) 2021 and when removed the needle from site the needle was missing.Does not feel it was a retracting syringe but not sure of item # or lot # still.Denied reuse of syringes.Consumer went to first doctors visit (b)(6) 2021 for a consult for this incident.Doctor looked at this site that he circled with ink.They will complete an xray on (b)(6) 2021 of the site marked plus a cysts that he has had before this incident.Consumer provided his email address.I will email him so he can update the contact tonight when he gets home.Sending mailing kit to home address for unused syringes from his supply.Wife discarded syringe in question.Dc from phone call on (b)(6) 2021 16:30:33: called out to this patient/consumer got him while he was driving to doctors for a review visit.Not able to ask a lot of questions or obtain product info.He does not know the item number at this time but will update bd tomorrow afternoon 1/15/2021.Dc email from rcc - consumer left voice message saying that he uses bd injection needles for testosterone injections.He reported that 1 or 2 have dislodged from the head of the needle and is currently stuck in his left backside.The consumer would like to know if he needs to get it out immediately and if there will be any damage consumer reported lot #: catalog#: date of event: samples status i tried to reach out to customer to get additional information.Left a voice message and advise someone would follow up.

• Brand Name: SYRINGE 3ML LL W/NDL 22X1 RB
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 11285827
• MDR Text Key: 230750161
• Report Number: 1213809-2021-00063
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903095728
• UDI-Public: 00382903095728
• Combination Product (y/n): N
• PMA/PMN Number: K980987
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309572
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/09/2021
• Date Manufacturer Received: 02/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1