MAUDE Adverse Event Report: BD (SUZHOU) PEN NEEDLE 31X8 ASIA

Catalog Number	320471
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/09/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that pen needle 31x8 asia bent and broke off during use.This occurred on 5 occasions.The following information was provided by the initial reporter: needle bending and breaking from the hub.The patient reported that she was switched to the bd micro-fine 8mm pen needle by the pharmacist when the novo 8mm was out of stock.She self injected on monday 9th march at 5 pm.When the injection was completed she pulled out the needle and noticed that the needle was missing from the hub.The needle had broken off and was stuck below the skin.She went to see her local gp about the missing needle and was sent for an ultrasound to find exactly where the needle was located.When the needle was located she had to go into a procedure to remove the needle.The procedure took 45 minutes and it left her with 3-4 stitches.The procedure was this morning.She has kept the broken needle and is happy to return the sample.She also reported that she had noticed some of the needles had bent after an injection.She is happy to return samples of the pen needle from this batch.
Additional Manufacturer Narrative
Investigation: customer returned (73) 31gx8mm bd pen needles - 72 were sealed/unused from lot 9064681 and 1 was returned after use without a tear drop label.Consumer reported needle bending and breaking from the hub.The pen needle that was returned after use was examined and it was observed that the patient end (pe) cannula was broken; the part of the pe cannula that had broken off was also returned.Microscopic examination of this pen needle and broken pe cannula revealed characteristics such as residual bends on the remaining pe cannula, and ovality (deformation from the normally circular cross section) ¿ removal of the epoxy made this evident.When viewed together these are all indicators of bending/re-straightening mode of failure.30 out of the remaining 72 pen needles returned sealed/unused were selected, then tested for visual inspection of point geometry, outer diameter and lube coverage.All 30 tested pen needles tested within specification.No evidence of manufacturing defect was observed.As per manufacturing: 1.Dhr was reviewed and no qn found.2.Manufacture records were reviewed, no abnormal was found.- confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (broken pe cannula) the possible root cause for this issue (broken pe cannula): user error.No evidence of manufacturing related issues were observed on the returned samples.Microscopic examination of the returned sample revealed characteristics such as residual bends on the remaining pe cannula, and ovality (deformation from the normally circular cross section).When viewed together these are all indicators of bending/re-straightening mode of failure.
Event or Problem Description
It was reported that pen needle 31x8 asia bent and broke off during use.This occurred on 5 occasions.The following information was provided by the initial reporter: needle bending and breaking from the hub.The patient reported that she was switched to the bd micro-fine 8mm pen needle by the pharmacist when the novo 8mm was out of stock.She self injected on monday 9th march at 5 pm.When the injection was completed she pulled out the needle and noticed that the needle was missing from the hub.The needle had broken off and was stuck below the skin.She went to see her local gp about the missing needle and was sent for an ultrasound to find exactly where the needle was located.When the needle was located she had to go into a procedure to remove the needle.The procedure took 45 minutes and it left her with 3-4 stitches.The procedure was this morning.She has kept the broken needle and is happy to return the sample.She also reported that she had noticed some of the needles had bent after an injection.She is happy to return samples of the pen needle from this batch.
Additional Manufacturer Narrative
H.6.Investigation: dhr was reviewed and no qn found.Manufacture records were reviewed, no abnormality was found.Appearance and np end were inspected for 7pcs retention parts, all results passed.Pen needle product has 100% iv end angularity inspection by visual system, and defect part will be rejected automatically.Base on investigation above, the certain cause cannot be concluded at the moment.
Event or Problem Description
It was reported that pen needle 31x8 asia bent and broke off during use.This occurred on 5 occasions.The following information was provided by the initial reporter: needle bending and breaking from the hub.The patient reported that she was switched to the bd micro-fine 8mm pen needle by the pharmacist when the novo 8mm was out of stock.She self injected on (b)(6) at 5 pm.When the injection was completed she pulled out the needle and noticed that the needle was missing from the hub.The needle had broken off and was stuck below the skin.She went to see her local gp about the missing needle and was sent for an ultrasound to find exactly where the needle was located.When the needle was located she had to go into a procedure to remove the needle.The procedure took 45 minutes and it left her with 3-4 stitches.The procedure was this morning.She has kept the broken needle and is happy to return the sample.She also reported that she had noticed some of the needles had bent after an injection.She is happy to return samples of the pen needle from this batch.

• Brand Name: PEN NEEDLE 31X8 ASIA
• Common Device Name: PEN NEEDLE
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9906789
• Report Number: 3006948883-2020-00106
• Device Sequence Number: 3355031
• Product Code: FMI
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 320471
• Device Lot Number: 9064681
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020; 03/11/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 04/02/2020; 04/15/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention