MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD NEEDLE 18X1-1/2 SB; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305199
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle could not attach to syringe, either hub tool short of needle cap too long, also, the hub was a different color than the rest of the lot numbers with a bd needle 18x1-1/2 sb.The following information was provided by the initial reporter: material no.305199, batch no.8117703.It was reported that the needle would not attach to the syringe and it was noted that the needle hub was a different color from the rest of the lot numbers.Per initial reporter email: ¿ could not attach the needle to the syringe.It appears the hub is too short or the needle cap is too long and there is no space to accommodate the attaching of the hub to the tip of the syringe.The needle hub is a different colour than others of the same lot number.
Additional Manufacturer Narrative
Investigation: no samples or photos were provided by the customer for investigation.A device history record (dhr) review was performed on the batch associated with this investigation.The dhr reviews did not reveal any defects or issues reported and no quality notifications were issued.Based on the investigation conclusion and without a sample to analyze, the conditions reported by the customer could not be confirmed nor could this symptom be correlated with a potential cause linked to the bd process.
Event or Problem Description
It was reported that the needle could not attach to syringe, either hub tool short of needle cap too long, also, the hub was a different color than the rest of the lot numbers with a bd needle 18x1-1/2 sb.The following information was provided by the initial reporter: material no.305199 batch no.8117703 it was reported that the needle would not attach to the syringe and it was noted that the needle hub was a different color from the rest of the lot numbers.Per initial reporter email: could not attach the needle to the syringe.It appears the hub is too short or the needle cap is too long and there is no space to accommodate the attaching of the hub to the tip of the syringe.The needle hub is a different colour than others of the same lot number.
Event or Problem Description
It was reported that the needle could not attach to syringe, either hub tool short of needle cap too long, also, the hub was a different color than the rest of the lot numbers with a bd needle 18x1-1/2 sb.The following information was provided by the initial reporter: material no.305199 batch no.8117703.It was reported that the needle would not attach to the syringe and it was noted that the needle hub was a different color from the rest of the lot numbers.Per initial reporter email: ¿ could not attach the needle to the syringe.It appears the hub is too short or the needle cap is too long and there is no space to accommodate the attaching of the hub to the tip of the syringe.The needle hub is a different colour than others of the same lot number.
Additional Manufacturer Narrative
H.6.Investigation: two (2) samples were provided by the customer for investigation.One (1) sample was in a baggie labeled ¿same lot #.Not defective.Keep for comparison / verification purposes¿.The second (2nd) sample was in a baggie labeled ¿defective sample¿.The non-conforming sample was show to quality control representatives who confirmed that the sample is lacking the proper color.The qc representatives also noted that the needle hub assembly had been pushed into the shield so far that the shield had cracked.During the molding process colorant is mixed with the resin prior to molding to provide the color.Therefore some color variation is normal; however, when the quality control representatives analyzed the return sample it was determined that this needle hub assembly was too light and should have been rejected if seen by an operator.It is likely that the needle hub assembly was not seen in process and was therefore not culled out.The quality control representatives also observed a crack in the needle shield due to the needle shield being pushing into the shield too far due to a machine malfunction when the needle shield was being placed on the needle hub assembly.This resulted in the condition observed by the customer of ¿there is no space to accommodate the attaching of the hub to the tip of the syringe.¿ a device history record review was completed with zero defects found.No quality notifications were written for this batch, nor for the associated assembly batches.H3 other text : see h.10.

• Brand Name: BD NEEDLE 18X1-1/2 SB
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• MDR Report Key: 8732365
• Report Number: 1911916-2019-00627
• Device Sequence Number: 14071851
• Product Code: FMI
• UDI-Device Identifier: 30382903051992
• UDI-Public: 30382903051992
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2019

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: Other
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: 305199
• Device Lot Number: 8117703
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 06/10/2019; 06/10/2019
• Initial Report FDA Received Date: 06/25/2019
• Supplement Report FDA Received Date: 07/03/2019; 07/31/2019
• 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: Other