MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ SYRINGE HEPARIN 27GAX1.2 ML; FLUSH

Catalog Number 324701

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd¿ syringe heparin 27gax1.2 ml contained plastic like foreign matter.No serious injury or medical intervention reported.

Event Description

It was reported that bd¿ syringe heparin 27gax1.2 ml contained plastic like foreign matter.No serious injury or medical intervention reported.

Manufacturer Narrative

Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.

Manufacturer Narrative

Investigation summary: a dhr review was completed and noted one notification [200641509] which did not pertain to this complaint cause.No other issues noted from this review.A complaint history check was performed but this lot number did not provide any information for this complaint.Severity: s2.No other related complaints were found.On 26jul2018, holdrege received one (1) loose 1ml, 1/2in, 26g sanofi pre-fill syringe from reported batch # 6088621.All samples are decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, the shield was initially removed and a small filament, appearing to be plastic-like, was noted along the outside of the cannula.The material appears to be what is termed "angelhair" within the manufacturing plant.Ftir analysis was completed on the strand of material observed on the cannula shaft.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is most likely polyethylene mixed with silicone.This indicates that this material is most likely the angel hair condition described below.Angelhair are small filaments of plastic material, generally composed of polyethylene, one of the component materials utilized in manufacturing of the syringes.These filaments are created during transport of components from one area/piece of equipment on the manufacturing floor to another via a pressurized tube transport system called pea-shooting.As plastic components ride through this system, occasionally, filaments, such as are noted within the received sample, can be generated and find their way into the final packaged product.Due to the frequency of occurrence, these filaments can make it through in-process inspections by certified operators, as well as automated systems utilized to inspect components/devices.The syringes undergo a sterilization process, which would include the foreign material, thus, the material represents more a cosmetic issue for the end user.Continuous improvement projects with the plant to help reduce angelhair being generated continue to be evaluated/implemented as deemed appropriate.Based on the investigation, no capa required at this time.

Event Description

It was reported that bd¿ syringe heparin 27gax1.2 ml contained plastic like foreign matter.No serious injury or medical intervention reported.

• Brand Name: BD¿ SYRINGE HEPARIN 27GAX1.2 ML
• Type of Device: FLUSH
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7735558
• MDR Text Key: 115678654
• Report Number: 1920898-2018-00552
• Device Sequence Number: 1
• Product Code: NZW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 324701
• Device Lot Number: 6088621
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2018
• Date Manufacturer Received: 07/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other